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Real-World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort.

Authors :
Pelle J
Briant AR
Branger P
Derache N
Arnaud C
Lebrun-Frenay C
Cohen M
Mondot L
De Seze J
Bigaut K
Collongues N
Kremer L
Ricard D
Bompaire F
Ohlmann C
Sallansonnet-Froment M
Ciron J
Biotti D
Pignolet B
Parienti JJ
Defer G
Source :
Neurology and therapy [Neurol Ther] 2023 Apr; Vol. 12 (2), pp. 529-542. Date of Electronic Publication: 2023 Feb 10.
Publication Year :
2023

Abstract

Introduction: Natalizumab, a therapy for relapsing-remitting multiple sclerosis (RRMS), is associated with a risk of progressive multifocal leukoencephalopathy (PML). Over the last several years, practitioners have used off-label extended interval dosing (EID) of natalizumab to reduce PML risk, despite the absence of a large-scale efficacy evaluation.<br />Methods: We conducted a retrospective, multicenter cohort study among adults with RRMS receiving stable standard interval dosing (SID), defined as a ≥ 12-month consecutive period of ≥ 11 natalizumab infusions/year in France. We compared the 12-month risk difference of remaining relapse-free (primary endpoint) between patients who switched to EID (≤ 9 natalizumab infusions) and those who remained on SID, with a noninferiority margin of - 11%. We used propensity score methods such as inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM). Secondary endpoints were annualized relapse rate, disease progression, and safety.<br />Results: Baseline characteristics were similar between patients receiving EID (n = 147) and SID (n = 156). The proportion of relapse-free patients 12 months postbaseline was 142/147 in the EID (96.6%) and 144/156 in the SID group (92.3%); risk difference (95% CI) 4.3% (- 1.3 to 9.8%); p < 0.001 for non-inferiority. There were no significant differences between relapse rates (0.043 vs. 0.083 per year, respectively; p = 0.14) or Expanded Disability Status Scale mean scores (2.43 vs. 2.72, respectively; p = 0.18); anti-JC virus index values were similar (p = 0.23); and no instances of PML were reported. The comparisons using IPTW (n = 306) and PSM (n = 204) were consistent.<br />Conclusion: These results support the pertinence of using an EID strategy for RRMS patients treated with natalizumab.<br />Clinical Trials: gov identifier (NCT04580381).<br /> (© 2023. The Author(s).)

Details

Language :
English
ISSN :
2193-8253
Volume :
12
Issue :
2
Database :
MEDLINE
Journal :
Neurology and therapy
Publication Type :
Academic Journal
Accession number :
36763307
Full Text :
https://doi.org/10.1007/s40120-023-00440-5